ClinicalTrials.gg
CompletedNCT07329907CA-SA/LAUpdated Aug 4, 2026

Combination Therapy for Warts: Candida Antigen vs. Topical Keratolytic

A Phase 2 interventional study of Salicylic Acid/Lactic Acid Topical Solution and Candida Antigen Intralesional Injection in Warts and Human Papilloma Virus (HPV), sponsored by Benha University. Completed at 1 site in Egypt. Open to participants aged 5 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-04.

Sponsored by Benha University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years after the study started (first participant enrolled Dec 2023, registered Dec 2025).
Phase
Phase 2
Study type
Interventional
Enrollment
126
Allocation
Randomized
Ages
5 Years to 60 Years
Sex
All
01

Study summary

Objective: To compare the efficacy, safety, and recurrence rates of topical salicylic acid/lactic acid (SA/LA) monotherapy (Group A), intralesional Candida antigen (CA) monotherapy (Group B), and their combination (Group C) for the treatment of warts.

02

Conditions studied

  • Warts
  • Human Papilloma Virus (HPV)

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Keywords

  • warts
  • verruca
  • candida antigen
  • intralesional immunotherapy
  • salicylic acid
  • lactic acid
03

In context

Warts

171 studies on the registry are indexed under Warts; 35 are open to participants now.

This study's enrollment of 126 is above the median of 70 across 155 interventional studies indexed under Warts.

Browse Warts studies →

Lead sponsor

Benha University is the lead sponsor of 362 studies on the registry; 66 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Single or multiple warts.
  2. Aged 5 to 60 years.
  3. Eligible for both topical and intralesional treatments.
  4. No prior wart treatment for at least 1 month.

Exclusion criteria

Exclusion Criteria:

  1. Pregnancy or lactation.
  2. or use of immunosuppressive drugs.
  3. Known sensitivity to study ingredients.
  4. Systemic/local inflammation or infection.
  5. History of bleeding/clotting disorder, or use of anticoagulants/NSAIDs.
  6. History of asthma, allergic skin disorders, or convulsions.
  7. History of chronic systemic diseases (renal/hepatic failure, cardiovascular disorders).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
126 participants (actual)

Study arms

  • Active comparator
    topical monotherapy

    Patients receive topical application of Salicylic Acid 40% and Lactic Acid 16% once daily for up to 6 weeks.

    Drug: Salicylic Acid/Lactic Acid Topical Solution

  • Active comparator
    Intralesional Monotherapy

    Patients receive intralesional injection of Candida Antigen (0.1-0.3 mL) every 2 weeks for up to 6 sessions.

    Biological: Candida Antigen Intralesional Injection

  • Active comparator
    Combination Therapy

    Patients receive intralesional injection of Candida Antigen (0.1-0.3 mL) every 2 weeks for up to 6 sessions, with topical Salicylic Acid 40% and Lactic Acid 16% applied in between.

    Combination Product: Candida Antigen and Salicylic Acid/Lactic Acid

Interventions

  • DrugSalicylic Acid/Lactic Acid Topical Solution

    Patients receive topical application of Salicylic Acid 40% and Lactic Acid 16% once daily for up to 6 weeks.

  • BiologicalCandida Antigen Intralesional Injection

    Patients receive intralesional injection of Candida Antigen (0.1-0.3 mL) every 2 weeks for up to 6 sessions.

  • Combination productCandida Antigen and Salicylic Acid/Lactic Acid

    Drug pages: Candida albicans · Salicylic Acid · Lactic Acid

    Patients receive intralesional injection of Candida Antigen (0.1-0.3 mL) every 2 weeks for up to 6 sessions, with topical Salicylic Acid 40% and Lactic Acid 16% applied in between.

06

What researchers measure

Primary outcomes

  1. Complete Response (CR) Rate

    Percentage of patients achieving complete disappearance of all warts.

    Time frame: 3 months post-treatment

Secondary outcomes

  1. Distant Wart Clearance Rate

    Percentage of patients achieving clearance of non-injected/distant warts.

    Time frame: 3 months post-treatment

  2. Recurrence Rate

    Percentage of patients with recurrence of warts after achieving CR.

    Time frame: 6 months post-treatment

  3. Safety and Tolerability Profile

    Incidence and severity of local (pain, edema, crustations) and systemic (flu-like symptoms) side effects.

    Time frame: At each visit (every 2 weeks) and 3 months post-treatment

07

Study locations

1 site
  • Outpatient Clinic of Dermatology, Venereology and Andrology Department at Benha University Hospitals
    Banhā, Qalyubia Governorate 13518, Egypt
08

References and documents

Individual participant data

Plan to share: Yes — What IPD will be shared? De-identified individual participant data that underlie the results reported in the final study, including demographic characteristics and ocular surface/meibomian gland assessment parameters. Supporting Documents: The study protocol and statistical analysis plan will be made available. When will data be available? Data will be available beginning 6 months and ending 36 months following the official publication of the study results. With whom? Data will be shared with qualified researchers who provide a methodologically sound proposal that is approved by the study investigators. For what types of analyses? To achieve the specific aims outlined in the approved research proposal. By what mechanism will data be made available? Interested researchers should contact the corresponding author via email to submit a formal request and a data use agreement.

Supporting information: Study protocol, Statistical analysis plan

Time frame: Data will be available beginning 6 months and ending 36 months following the official publication of the study results.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07329907
Lead sponsor
Benha University
Responsible party
Ghada Mohamed Shams (Principal investigator, Benha University) — Principal investigator
First posted
Jan 9, 2026
Start date
Dec 1, 2023
Primary completion
Jun 1, 2024
Completion
Dec 30, 2024
Last update
Aug 4, 2026

Study contacts

Ghada Shams
principal investigator · Benha University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Candida albicans · Salicylic Acid · Lactic Acid

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